Have faster drug approvals led to more dangerous drugs?

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Have faster drug approvals led to more dangerous drugs?

Newer medications that got the green light from the US Food and Drug Administration had more than a one in four likelihood of receiving a black box warning or being withdrawn from the market within 25 years of their approval. That compares to one in five drugs in 1992, the year Congress passed legislation to allow the FDA to collect pharmaceutical industry fees to speed drug approvals.

Those findings were based on a study published last Monday in the journal Health Affairs, in which researchers from Cambridge Health Alliance, Boston Medical Center, and elsewhere reviewed the most recent data from the Tufts Center for Drug Development to determine how many of the 748 medications approved from 1975 to 2009 wound up being taken off the market or having a black box placed on their label — the FDA’s way to warn doctors and patients about the most dangerous potential side effects.

But the study couldn’t prove that the expedited drug approval process led to more dangerous drugs being allowed on the market. It’s possible, for example, that the FDA has put more demands on drug companies to evaluate the safety of their drugs after they are approved for sale.

“We have no good evidence that this is actually happening,” said study leader Dr. Cassie Frank, a primary care physician at Cambridge Health Alliance. Her approach for prescribing medications to patients? She waits for any new drug to be on the market for at least seven years before prescribing it to patients — unless it’s a novel, breakthrough medication. D.K.

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